The Molecular Diagnostics Laboratory (MDL) plays a vital role in safeguarding public health by conducting quality control testing of molecular diagnostic kits manufactured indigenously and also imported into the country. The laboratory evaluates a broad spectrum of in-vitro diagnostic (IVD) kits, including qualitative assays for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV), as well as quantitative viral load tests for HBV DNA, HCV RNA, and HIV-1 RNA. In addition, the laboratory tests multiplex blood donor screening assays for HBV, HCV, and HIV detection. These kits are forwarded to the laboratory by the Central Drugs Standard Control Organization (CDSCO), its zonal offices, the procurement division of the National AIDS Control Organization (NACO), and other government agencies.

The laboratory is distinct in actively undertaking research activities in parallel with its regulatory and testing functions, thereby integrating innovation with routine quality assurance. The laboratory conducts focused research to improve the efficiency, standardization, and reliability in molecular diagnostics. A notable contribution of the laboratory is the optimization of panel size for HBV and HCV viral load monitoring kits, demonstrating that diagnostic accuracy can be maintained with reduced panel sizes while lowering cost and operational complexity.

The laboratory operates under a well-established Quality Management System and is accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL), Quality Council of India (QCI), New Delhi, in compliance with ISO/IEC 17025:2017 standards for the Quality Control testing of molecular diagnostic kits, holding NABL accreditation certificate number TC-7725. Furthermore, the laboratory has been a consistent and successful participant in the External Quality Assurance Scheme (EQAS) for Nucleic Acid Testing (NAT) conducted by the National Reference Laboratory (NRL), Australia, for decades. This participation includes proficiency testing for HBV DNA viral load, HCV RNA viral load, HIV-1 RNA viral load, and multiplex blood screening NAT, thereby ensuring the reliability and accuracy of test results.

In the absence of statutory standards laid down in the Indian Pharmacopoeia or other pharmacopoeias for testing medical devices in this category, the laboratory follows guidelines issued by the CDSCO, New Delhi and the World Health Organization (WHO), Geneva, for evaluating performance characteristics of molecular diagnostic kits. The evaluation parameters include sensitivity, specificity, and accuracy. The laboratory employs well-characterized molecular reference panels derived from human plasma, and their performance is rigorously validated using primary reference materials obtained from the National Institute for Biological Standards and Control (NIBSC), United Kingdom.

The laboratory receives IVD samples under various regulatory provisions, including Form MD-15 and Form MD-9 for batch testing under import and manufacturing licenses for commercial purposes, and Form MD-17 and Form MD-13 for performance evaluation under import and manufacturing licenses for testing purposes. Upon completion of testing, reports are submitted to the Drugs Controller General of India (DCGI) and related stakeholders. The laboratory, under the provisions of the Medical Device Rules, 2017, is supported by duly notified Medical Device Testing Officers (MDTOs), authorized to undertake testing of molecular diagnostic kits under Form MD-38 with All India jurisdiction at NIB, Noida, as per Gazette Notification S.O. 912(E) dated February 18, 2026. Before this, authorization for testing of in vitro diagnostic (IVD) devices under Form MD-38 was held in accordance with Gazette Notification S.O. 5331(E) dated December 10, 2024.

Beyond its regulatory and testing functions, the Molecular Diagnostics Laboratory plays an important role in capacity building and skill development. It conducts training under the National Skill Development and Hands-on Training Programme organized by the National Institute of Biologicals (NIB), Noida, for students from various National and International Institutes and Universities. The laboratory also offers structured training programs in molecular techniques and actively supervises undergraduate and postgraduate dissertation work, thereby contributing to academic and professional development in molecular diagnostics.

Salient Recent Publications

1. Misra G*, Gupta M, Singhal R, Qaisar S, Singh P, Anvikar AR. Strategic Approach to Enhancing Diagnostic Precision: Optimizing Panel Size for HBV and HCV Viral Load Monitoring Kits. Journal of Medical Virology. 2025 Jun;97(6):e70437.

2. Singh P, Misra G*, Mishra N, Anvikar A, Potdar V. Development and validation of novel RT-PCR assay for molecular diagnostic of viral variants using SARS-CoV-2 as a case study. Methods. 2025 Aug 1;240:54-62.

3. Misra, G*, Manzoor, A, Chopra, M. et al. Genomic epidemiology of SARS-CoV-2 from Uttar Pradesh, India. Sci Rep 13, 14847 (2023).

4. Chand T, Dubey AK, Misra G*. Unraveling HPV-associated cancer complexity: From molecular insights to innovative therapies. Heliyon. 2025 Feb 15;11(3).

5. Anoop Kumar, Supriya Saini, Anup Anvikar, Neelima Mishra, Gauri Misra*, (2025). The evolving landscape of emerging virus diagnosis: Challenges and Innovations, Molecular Biotechnology

6. Kumar A, Misra G*, Mohandas S, Yadav PD. Multi-epitope vaccine design using in silico analysis of glycoprotein and nucleocapsid of NIPAH virus. PloS one. 2024 May 10;19(5):e0300507

7. Anoop K, Neeraj S, Anupkumar RA, Gauri M*. (2024) Monkeypox virus: Insights into Pathogenesis and Laboratory Testing Methods. 3 Biotech, 2024

8. Misra G*, Hora S, Ginwal S, Singh N, Anvikar A. SARS-CoV-2 Variants Impact on Key Signaling Pathways Metamorphoses into Severity. Brazilian Archives of Biology and Technology. 2023 May 22;66:e23220261

Salient International Books

1. Misra G, editor. Quality Control and Regulatory Aspects for Biologicals: Regulations and Best Practices. Taylor and Francis Group, CRC Press; 2024.

2. Arivaradarajan P, Misra G. Omics Approaches, Technologies And Applications. Springer, Singapore; 2018

Salient Book Chapters

1. Satyajeet Singh, Manika P Sharma and Gauri Misra, ‘Regulatory Bodies: European Medicines Agency (EMA) and Pharmaceutical Inspection Co-operation Scheme (PIC/S)’ in Quality Control and Regulatory Aspects for Biologicals: Regulations and Best Practices”, 2024, Ed. Gauri Misra, Taylor & Francis, CRC Press, Boco Raton.

2. Bhartendu Sharma, Priyanshi Singh, Supriya Shukla and Gauri Misra, ‘Good Manufacturing Practices in Quality Control’ in Quality Control and Regulatory Aspects for Biologicals: Regulations and Best Practices”, 2024, Ed. Gauri Misra, Taylor & Francis, CRC Press, Boco Raton.